Moderator
Rosalind Vo, MD
Panelists
Sara K Sella, MD
Pooja Khamar, MD, PhD
Viewing Papers
Expand a paper title to the right to view the paper abstract and authors. Use the video link to jump to that poster in the session.
Presenting Author
Nicole R. Fram, MD, ABO
Co-Authors
Preeya Gupta MD, Aimee Edell MD, Julio Echegoyen PhD, MD, Kavita Dhamdhere MD, PhD, Elizabeth Yeu MD
Purpose
The purpose of this study was to explore the relationship between the clinical outcomes and patient reported outcomes (PROs) in Demodex blepharitis (DB) patients compared to patients without DB.
Methods
Janus was an observational, multicenter, cross-sectional, prospective parallel cohort (control: 0 collarettes; DB cohort: ?1 collarettes) study. Patients, at least 18 years old, with a CDVA of 20/100 or better in each eye were enrolled. Patients with moderate to severe dry eyes were excluded. Key clinical outcomes (collarette density and lid margin erythema) and PROs using visual analog scale (VAS, 0-100), and most bothersome ocular PROs were collected.
Results
Mean VAS score for itching (25 vs 15, p=0.02), fluctuating vision (24 vs 10, p<0.001), irritation="" (28="" vs="" 17,="" p="0.02)," and="" redness="" (20="" vs="" 10,="" p="0.01)" were="" significantly="" worse="" in="" the="" db="" group="" compared="" to="" the="" control="" group,="" respectively.="" clinically="" meaningful="" differences="" (?="" 7-points)="" in="" vas="" scores="" were="" recorded="" in="" db="" patients="" compared="" to="" those="" without="" db="" (i.e.,="" vas="" score="" differences="" of="" 9.5="" for="" itching,="" 14.4="" for="" fluctuating="" vision,="" 10.3="" for="" irritation="" and="" 9.9="" for="" redness).="" itching="" along="" the="" lid/lash="" margin="" was="" the="" most="" frequently="" reported="" and="" bothersome="" symptom="" in="" db="" patients,="" and="" dryness="" was="" the="" most="" reported="" symptom="" in="" patients="" without="">
Conclusion
Patients with Demodex blepharitis exhibit significantly worse symptoms than those without. This study further confirms previous findings that DB patients report itching to be the most bothersome and frequently reported symptom.
Presenting Author
Darrell E. White, MD
Co-Authors
Thomas Chester OD, Jillian Ziemanski OD, PhD, Moataz Razeen MD, Jason Vittitow PhD, Preeya Gupta MD
Purpose
Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This study evaluated patient-reported symptoms early in treatment with PFHO.
Methods
This prospective, multicenter, open-label, phase 4 study (NCT06309953) enrolled adults with a history of DED for ?6 months. PFHO was instilled in both eyes 4 times daily for 14 days. Patients completed early outcome surveys during 4 clinic visits (baseline and days 3, 7, and 14). The primary outcome (symptom severity) is presented separately. Secondary outcomes included patient-reported frequency of (percentage of time experiencing) the most bothersome symptom, awareness of dry eye symptoms, and fluctuations in quality of vision.
Results
The �most bothersome� symptom at baseline (n=99 patients) was eye dryness (28.3%), blurred vision (17.2%), eye irritation (14.1%), light sensitivity (13.1%), eye tiredness (12.1%), burning/stinging (11.1%), or eye itching (4.0%). Mean frequency (percentage of time) experiencing the most bothersome symptom decreased significantly (P<0.0001) from="" 77.9%="" at="" baseline="" to="" 46.7%="" at="" day="" 3,="" 41.3%="" at="" day="" 7,="" and="" 34.7%="" at="" day="" 14.="" significant=""><0.0001) decreases="" were="" also="" observed="" in="" mean="" frequency="" of="" awareness="" of="" dry="" eye="" symptoms="" (77.6%="" at="" baseline,="" 39.7%="" at="" day="" 3,="" 32.6%="" at="" day="" 7,="" 27.6%="" at="" day="" 14)="" and="" fluctuations="" in="" quality="" of="" vision="" (62.8%="" at="" baseline,="" 29.8%="" at="" day="" 3,="" 24.5%="" at="" day="" 7,="" 19.4%="" at="" day="">
Conclusion
Early in the course of treatment with PFHO, patients with DED experienced significant reductions in the frequency of dry eye symptoms, including the patient-specific most bothersome symptom.
Presenting Author
Siri P. Yalamanchili, MD
Co-Authors
Albert Cheung MD, Edward Holland MD, Justin Riffel MD, Kurt Hanebrink MD, Erin Rolfes OD, MS, Adam Leone BA, Benjamin Likins MD
Purpose
The goal of our study is to highlight the results of a steroid-sparing systemic immunosuppressive regimen for patients with limbal stem cell deficiency (LSCD) undergoing ocular surface stem cell transplantation (OSST).
Methods
This retrospective chart review studied patients with LSCD undergoing OSST from 2014 to 2023, evaluating the evolving steroid-sparing systemic immunosuppression regimen over the years. Inclusion criteria encompassed patients aged 18-69 with LSCD due to aniridia, contact lens use, thermal or chemical injury, Steven-Johnson Syndrome, mucous membrane pemphigoid, or other severe ocular surface disease. Outcome measures included ocular surface stability, visual acuity, and rates of rejection/failure. Steroid dosage and length of taper, along with any steroid-related side effects, were recorded for each patient.
Results
There were 166 eyes that met the inclusion criteria. The average starting dose of oral prednisone was 34.6 milligrams, with an average taper length of 13.8 weeks. There were 66 eyes that underwent a keratolimbal allograft, 96 eyes that underwent a living-related conjunctival limbal allograft, and 28 eyes that underwent a conjunctival limbal autograft. At the last follow up, 72.3% of eyes had a stable ocular surface and 59.6% had improvement in vision of at least two lines. 19.3% of eyes developed rejection and 13.3% developed failure during the follow up period. Our rejection rate was significantly lower than our prior reported rejection rate of 53.9% (p< />
Conclusion
A modified steroid-sparing immunosuppression protocol for OSST has shown significant efficacy in restoring the ocular surface of patients with LSCD. A steroid-sparing immunosuppressive regimen mitigates the side effects related to oral steroid usage, without compromising the stability of the stem cell graft.
Presenting Author
Ghada Aljuhani, MBBS
Co-Authors
Abdulrahman Alahmadi MBBS
Purpose
Sjogren syndrome is an autoimmune disease with ocular involvement, particularly dry eye disease (DED). This review and meta-analysis aimed to assess the effectiveness of topical tacrolimus and cyclosporine in managing DED secondary to Sjogren syndrome.
Methods
We performed a systematic review and meta-analysis of five randomized controlled trials using Google Scholar and PubMed databases. Our review comprised a sample of 230 eyes. Outcome measures included the values of the Schirmer I test, tear breakup time (TBUT), and the number of patients who developed adverse effects.
Results
We found no significant difference in the Schirmer I test score between tacrolimus and cyclosporine. The pooled mean differences were (-1.02 mm; 95% CI: -3.72, 1.68; p = 0.46) for tacrolimus and (-1.50 mm; 95% CI: -3.29, -0.28; p = 0.10) for cyclosporine. According to TBUT, the cyclosporine group improved significantly compared to the tacrolimus group.
Conclusion
Both medications have the advantage of improving Sjogren syndrome-induced DED; however, cyclosporine significantly improved TBUT. We need more research to validate these findings and develop a treatment strategy for DED due to Sjogren syndrome.
Presenting Author
Eric D. Donnenfeld, MD, FACS
Purpose
Dry eye disease (DED) is a debilitating progressive condition associated with hyperosmolarity and an increase in inflammation. DED may compromise eligibility for surgery as well as represent an unfortunate sequala of many procedures. This study evaluated the efficacy of lifitegrast 5.0% in improving the signs and symptoms of DED over 12 weeks.
Methods
This was a prospective, observational case series study of adult patients with DED (based on ocular surface disease index [OSDI] ?25, clinical findings and osmolarity in at least 1 eye ?312 mOsm/L) performed at 4 study centres. Participants were instructed to instil 1 drop per eye twice daily for the 12-week study period. Participants were assessed using the OSDI symptom questionnaire, tear osmolarity, matrix metalloproteinase-9 (MMP-9) testing, slit-lamp examinations, Schirmer�s test, tear film break-up time, corneal staining, meibomian grading and conjunctival staining at each study visit. Visits were scheduled at Baseline, 2 weeks (Visit 2), 6 weeks (Visit 3) and 12 weeks (Visit 4).
Results
50 participants were recruited and completed all visits. At Baseline, mean (95%CI) OSDI was 52.2 (48.0�56.5) and tear osmolarity was 317 mOsm/L (314�319). At Visit 4, there was a statistically significant improvement in OSDI (mean [95%CI] 31.2 [27.5�30.0]; p<0.001) and="" tear="" osmolarity="" (293="" [290�297];=""><0.001). improvements="" were="" also="" observed="" (baseline="" vs="" visit="" 4)="" for="" schirmer�s="" test="" (11.66="" vs="" 17.35;=""><0.001), tear="" film="" break-up="" time="" (8.1s="" vs="" 10.4s;=""><0.001) and="" lissamine="" green="" testing="" (1.03="" vs="" 0.12;=""><0.001). there="" was="" no="" change="" in="" mmp-9.="" most="" eyes="" showed="" improvements/no="" change="" in="" slit-lamp="" examinations="" and="" lid="" margin="" or="" meibomian="" gland="" assessments.="" there="" were="" no="" reports="" of="" adverse="">
Conclusion
Lifitegrast 5.0% effectively improved clinical signs and biomarkers in patients with DED, with improvements seen as early as 2 weeks.
Presenting Author
Tu M Tran, MD, MSc
Co-Authors
Christine Kim BA, Marjan Farid MD, Olivia Lee MD, Jordan Jessen BSc, Sarah Guo MD, Blaze Ann Carbonell BSc
Purpose
Purpose: To evaluate the impact of topical glaucoma medications on meibomian gland structure by correlating quantity of exposure to standardized infrared meibography grading.
Methods
At a major academic quaternary referral eye hospital, patients exposed to topical glaucoma medications underwent meibographic imaging with LipiView II (J&J Vision). Images were assigned average meiboscores by 4 independent graders, while a machine-learning algorithm was deployed grade. Age and sex matching of meiboscores was done with eyes without exposure to glaucoma topical medications. Exclusion criteria are: eyes that had intraocular surgery within the past 3 months, structural abnormalities precluding meibography, existing significant ocular surface disease (eg. limbal stem cell deficiency), and status post glaucoma incisional surgery or penetrating/lamellar corneal transplantation.
Results
The data will be updated immediately before presentation if accepted. The primary endpoint will occur in at least 150 eyes exposed to glaucoma medications and 150 eyes serving as normal controls (n = 300). A dose-response curve will be provided enabling practitioners to predict a meiboscore based on quantity of topical glaucoma medication exposure including duration, type of medication, cumulative dosing per medication. Additional factors such as age, contact lens wear, and screen time will be incorporated.
Conclusion
Topical glaucoma medication impacts meibomian gland structure and using the novel data generated by this study, practitioners without routine access of meibomian gland imaging can more accurately estimate their patients� meibomian gland status and direct therapies more appropriately.
Presenting Author
Preeya K. Gupta, MD
Co-Authors
Mitchell Shultz MD, Patrick Vollmer OD, Leslie O'Dell OD, Kavita Dhamdhere MD, PhD, Elizabeth Yeu MD
Purpose
Demodex infestation has been implicated in meibomian gland dysfunction (MGD). A meta-analysis of two studies evaluated the safety and efficacy of lotilaner ophthalmic solution, 0.25% (ERSA) compared with vehicle control (RHEA) in Demodex blepharitis (DB) patients with MGD.
Methods
ERSA is a randomized, double-masked study in DB patients with concomitant MGD (n=39) randomly assigned to receive a 12-week course of lotilaner ophthalmic solution, 0.25% twice daily (BID) or three times daily (TID), whereas RHEA is a randomized vehicle study in DB patients with concomitant MGD (n=40) evaluating vehicle control dosed BID, TID, or cross-over. Measures of meibum quality, meibomian gland function, patient-reported outcomes (PROs), and safety were evaluated. BID and TID results in both studies were not statistically different and therefore combined; meta-analysis of ERSA and RHEA compared lotilaner ophthalmic solution, 0.25% with vehicle control.
Results
At day 85, statistically significant improvements (p<0.001) from="" baseline="" were="" observed="" in="" the="" lotilaner="" ophthalmic="" solution,="" 0.25%="" group="" in="" mean="" meibomian="" gland="" secretion="" score="" (11.1�7.3),="" mean="" number="" of="" glands="" secreting="" clear="" liquid="" (5.1�4.0),="" mean="" number="" of="" glands="" yielding="" any="" liquid="" (5.4�4.4),="" while="" vehicle="" control="" did="" not="" show="" statistical="" improvements.="" results="" were="" also="" statistically="" significant="" compared="" with="" vehicle="" group=""><0.01). statistically="" significant="" improvements="" in="" pros="" (e.g.,="" itching="" and="" redness)="" were="" also="" observed="" in="" the="" lotilaner="" ophthalmic="" solution,="" 0.25%="" group="" at="" day="" 85=""><0.01). no="" serious="" drug-related="" adverse="" events="" were="" observed="" in="" either="">
Conclusion
Lotilaner ophthalmic solution, 0.25% demonstrated statistically significant improvements in measures of meibum quality, meibomian gland function and patient-reported symptoms at 12 weeks compared with baseline and vehicle control. Lotilaner ophthalmic solution, 0.25% was well tolerated with a similar safety profile as the vehicle group.
Presenting Author
Michael Mimouni, MD
Co-Authors
Yael Sharon MD, Margarita Safir MD, Itamar Arbel MD, Yoav Nahum MD, Gilad Rabina MD, Oriel Spierer MD
Purpose
To examine the safety and efficacy of combined treatment with topical ivermectin 1% and intense pulsed light (IPL) for dry eye disease (DED) secondary to demodicosis.
Methods
A retrospective review of medical files of patients treated at a private clinic specializing in DED between November 2022 and February 2024 was performed. Sixty-one patients aged 18 years or older with DED due to demodex blepharitis, who received the IPL and ivermectin 1% combination therapy were included. IPL was applied to the periocular area 4 times at 2-3-week intervals, and ivermectin 1% once daily for 1-2 months. Both eyes (n=122) of each patient were evaluated before and immediately after treatment cessation. Blepharitis, meibomian gland secretion, corneal staining, patient satisfaction and overall clinical improvement were recorded.
Results
Mean age was 59.6�17.6 years and 50.8% (n=31) were males. Meibomian gland secretion grading improved significantly after treatment from 2.74�0.63 to 1.63�0.63 (p<0.001). blepharitis="" was="" eliminated="" after="" treatment="" in="" 77.0%="" of="" patients="" (23.0%="" after="" treatment="" versus="" 100.0%="" before,=""><0.001). the="" patient="" satisfaction="" rate="" was="" moderate="" to="" high="" (range="" 0-2,="" mean="" 1.54�0.60).="" clinical="" improvement="" rate="" was="" moderate="" to="" high="" as="" well="" (range="" 0-2,="" mean="" 1.52�0.50).="" no="" significant="" side="" effects="" were="">
Conclusion
The combined treatment of topical ivermectin and IPL application to the facial area induced significant reduction of meibomian gland secretion and blepharitis along with high rate of patient satisfaction in DED. Further randomized controlled double-blinded studies are needed.
Presenting Author
John D. Sheppard, MD, MSc, FACS
Co-Authors
Priya Mathews MPH, MD, Sonja Krosser PhD
Purpose
Cyclosporine (CsA), a lipophilic cyclic peptide that inhibits T cell-dependent lymphokine production, is the active pharmaceutical ingredient (API) in several topical medications. Post hoc dry eye disease clinical trial data demonstrates that FDA approved CsA 0.1% solution in a semi-fluorinated alkane vehicle (Vevye� US) affects MMP-9 expression.
Methods
CsA 0.1% solution demonstrated increased bioavailability, rapid efficacy onset, and tolerability in multiple dry eye disease (DED) studies. In ESSENCE-1, 328 patients were enrolled in a prospective, 12-week, multicenter, randomized, double-masked, confirmatory, vehicle-controlled clinical study. Masked subjects diagnosed with a history of DED were randomized to receive either water-free CsA or vehicle twice daily. MMP-9 levels were assessed by the InflammaDry Test� (QuidelOrtho, San Diego, CA). Subjects positive in the worst eye for MMP-9 at baseline were included in this analysis.
Results
Matrix metalloproteinase-9 (MMP-9) is a commonly used clinical point of service diagnostic biomarker for detecting ocular surface inflammation. At baseline MMP-9 positive tested patients were similar in both cohorts: N=71/162 (43.8%) CsA group, and N=72/166 (43.4%) Semi-fluorinated alkane vehicle group. At Day 29 MMP-9 positivity for the CsA group was reduced by 18 subjects (-25.4%, p=0.0171), whereas in the vehicle group MMP-9 positivity was reduced by 2 subjects (-2.8%, p=0.811).
Conclusion
DED is in part driven by inflammation. This analysis demonstrates that novel water-free CsA BID therapy rapidly reduces inflammatory biomarker positivity in patients with DED after one month of treatment. Measuring MMP-9 could serve as a valuable diagnostic tool to further characterize DED patients and determine treatment strategy.
Presenting Author
P. Dee G. Stephenson, MD, FACS, ABO
Co-Authors
Cynthia Matossian MD
Purpose
This study is the first to evaluate the effect of varenicline solution nasal spray 0.03 mg (VNS) on signs and symptoms of dry eye disease (DED) and tear film stability as measured by the Cassini imager. The Cassini imager is an objective tool to assess the tear film using surface regularity index (SRI) and surface asymmetry index (SAI) in DED.
Methods
This prospective study aimed to enroll 50 subjects with DED. Subjects were randomized 1:1 to receive either VNS or vehicle-control (VC) nasal spray twice daily for 28 days. Primary endpoints included mean change of surface regularity index (SRI) and surface asymmetry index (SAI) as measured by the Cassini Imager from baseline (BL) to 15 mins post use VNS at Day 1. Secondary endpoints included mean change in SRI, SAI, corneal fluorescein staining (CFS), tear breakup time (TBUT), eye dryness score (EDS) and dry eye questionnaire score (DEQS) from BL to Day 28.
Results
50 subjects completed the study. At Day 1, the mean change in SRI and SAI in the VNS group,15 mins post use was 0.17 � 0.08 (p=0.668) and 0.71 � 0.34 (p=0.443), respectively. On Day 28, SRI and SAI improved to 0.14 � 0.11 (p=0.145) and 0.56 � 0.41 (p=0.03), respectively. A statistically significant improvement in the VNS group as compared to VC group was observed in mean CFS scores (55% vs.18%; p<0.001), eds="" (44%="" vs.="" 27.2%;="" p="0.012)" and="" deqs="" (13%="" vs.="" 1.5%;="" p="0.008)." while="" not="" statistically="" significant,="" tbut="" had="" a="" greater="" improvement="" in="" the="" vns="" group="" than="" in="" the="" vc="" group="" (69%="" vs="" 29%;="" p="0.68)." there="" were="" no="" serious="" adverse="">
Conclusion
Improvement in Cassini imager SAI at Day 28 provides first-time objective evidence that VNS fosters tear film stability over time. Further, this is the first study to show significant changes in CFS with use of VNS, The signs and symptoms outcomes in this study substantiate existing data that VNS is efficacious in achieving ocular homeostasis.
Presenting Author
P. Dee G. Stephenson, MD, FACS, ABO
Co-Authors
Cynthia Matossian MD, FACS
Purpose
Explore the prevalence of decreased corneal sensitivity in patients who have undergone cataract surgery, with or without relaxing incisions for correction of astigmatism.
Methods
Data for adult patients with normal corneal sensation (Cochet-Bonnet esthesiometry ? 50 mm) who underwent uneventful unilateral or bilateral cataract surgery and visited the clinic for routine postoperative examination, including corneal esthesiometry, at 6 and 12 months post cataract surgery were retrospectively evaluated. Eyes with a history of herpes simplex keratitis/herpes zoster, ocular trauma, corneal scarring, active infection or severe vision loss were excluded. Outcome measures include mean change in corneal sensitivity from preop to 6 and 12 months, and the percentage of eyes with esthesiometry <50 mm="" at="" 6="" and="" 12="">
Results
TBD
Conclusion
TBD
Presenting Author
Kimia Rezaei, BSc
Co-Authors
Koroush Shahraki MBBS, Olivia Lee MD, Lauren Chen MD, Shaden Yassin MD, Donny Suh MD
Purpose
Cystinosis is a rare genetic disorder causing cystine crystals to build up, leading to eye issues like photophobia, corneal erosions, and vision loss. Early detection is crucial, but current grading systems are inconsistent. The UCI Cystinosis Corneal Crystal Scoring (CCCS) system provides a five-stage method to assess corneal involvement.
Methods
An observational study was conducted on 36 cystinosis patients. Slit-lamp examination (SLE) images were taken of each eye. To ensure consistency and reliability, inter-rater reliability was assessed by having experts in the field independently score the collected images as well as a subset of SLE images available in published literature. All images were graded by two masked, expert graders. Two graders independently graded all the images to determine inter-grader reliability. One grader regraded the images after 3 days to determine intra-grader reliability. Intraclass correlation coefficient (ICC) and inter-rater agreement statistic (?) calculations were performed.
Results
A total of 111 images, including 75 from published literature and 36 from cystinosis patients, were graded using the UCI Cystinosis Corneal Crystal Scoring (CCCS) system. The inter-rater agreement was high (? = 0.869), and the intra-rater reliability was excellent (ICC = 0.922). The UCI CCCS demonstrated strong consistency among graders, providing a reliable quantitative assessment for corneal crystal deposition across different stages of the disease. This validation suggests that the UCI CCCS system can effectively capture corneal involvement severity and monitor changes over time.
Conclusion
The UCI CCCS is a reliable, reproducible, and standardized method for assessing corneal crystal involvement in cystinosis. Its robust inter- and intra-rater reliability supports its use in clinical and research settings for monitoring disease progression and treatment response.
Presenting Author
Jose R. Giraldo, MD
Co-Authors
Jose Arthur Milhomens Filho MD, Melisa Karslioglu MD, Hannah Cho BA, Maria Del Valle Estopinal MD, Olivia Lee MD, Chenchen Niu MD, PhD
Purpose
Conjunctival melanocytic intraepithelial lesions (CMIL) have risk of progression to melanoma. The purpose of this study is to correlate in vivo confocal microscopy (IVCM) and anterior segment optical coherent tomography (AS-OCT) imaging of conjunctival lesions with the histopathologic findings focused on intraepithelial melanocytes.
Methods
A prospective study of conjunctival lesions undergoing surgical excision was performed. Pre-operatively, patients underwent confocal microscopy (HRT3 RCM, Heidelberg Engineering, Heidelberg, Germany) and AS-OCT (HRA + OCT Spectralis, Heidelberg Engineering, Heidelberg, Germany) imaging through the lesion of interest. The IVCM images were examined with attention to conjunctival epithelial cell morphology and reflectivity. Conjunctival epithelial layer thickness and changes in reflectivity on AS-OCT were analyzed. All lesions were removed surgically, and histopathologic examination was performed in a blind fashion.
Results
Melanocytic abnormalities were found in 82% of the 17 conjunctival lesions included in this study. Eleven (64%) lesions represented non-premalignant melanocytic lesions (2 compounds nevus, 4 benign epithelial melanosis, and 5 with increased number of melanocytes without cytologic atypia). Three lesions CMIL with atypia (18%) were identified (2 low-grade and 1 high-grade). Eighteen percent of the lesions demonstrated no evidence of melanocytic alterations. AS-OCT showed increased epithelial thickness with patchy intraepithelial hyperreflectivity in the low-grade lesions and linear pattern in the high-grade lesion. IVCM images showed variable findings of abnormal cells in the epithelial layer.
Conclusion
Conjunctival lesions can harbor intraepithelial melanocytic abnormalities with malignant potential which might be detected by non-invasive imaging studies. Our findings suggest that CMIL with atypia can be suspected by examining AS-OCT and IVCM images and verified with histopathology.
Presenting Author
Olivia L. Lee, MD, ABO
Co-Authors
Jose Arthur Milhomens Filho MD, Melisa Karslioglu MD, Jose Giraldo MD, Jordan Tang BSc, Cinthia Kim MD, Alex Tran BSc, Sarah Guo MD, Fatima Elghazali BSc, Nobuyoshi Unno BSc
Purpose
Recombinant human nerve growth factor (Cenergermin 0.002%) has clinical efficacy in corneal epithelial healing in eyes with neurotrophic keratitis (NK). This study correlates multimodal imaging with clinical endpoints to evaluate the longitudinal efficacy of Cenegermin for NK stages 1-3 up to 12 months after treatment.
Methods
A retrospective review of NK eyes treated with an 8-week course of cenergermin and completed 1 year of follow-up were retrospectively analyzed. Corneal sensation using Coche-Bonnet esthesiometry, tear MMP-9 levels, and imaging of the cornea using slit lamp photography and in vivo confocal microscopy (IVCM) were recorded at baseline and compared to 4 weeks, 8 weeks, 12 weeks, 6 months, and 1 year after initiation of the treatment. IVCM images were analyzed for epithelial wing and basal cell density, corneal nerve parameters (density, reflectivity and tortuosity),and dendritic cells density.
Results
Twenty eyes of 20 patients were analyzed (stage 1 = 8, stage 2 = 8, and stage 3 = 4). Amongst the 12 eyes with epithelial defect (ED) at baseline, 91.67% were healed by 56 � 36 days. The mean epithelial cell density improved from 2199 � 1486 cells/mm� to 3393 � 1276 cells/mm� (p=0.004) in the wing layer, and from 3202 � 2707 cells/mm� to 5835 � 2021 cells/mm� (p<0.001) in="" the="" basal="" layer="" at="" 12="" months="" post-treatment.="" the="" mean="" corneal="" sensation="" improved="" from="" 1.13="" �="" 1.65cm="" to="" 3.15="" �="" 2.16cm="" (p="0.006)," which="" correlates="" to="" the="" increase="" in="" corneal="" nerve="" density="" (0.0351="" �="" 0.0974="" mm/mm�="" at="" baseline="" to="" 0.5892="" �="" 0.6413="" mm/mm�="" at="" 1-year="" follow-up="" [p="">
Conclusion
Topical Cenegermin achieves epithelial healing in eyes with NK that is sustained for months after treatment conclusion. This longitudinal study corroborates the long-lasting clinical effect of rhNGF treatment with structural and functional improvement exhibited by the corneal epithelium and corneal nerves.
Presenting Author
Diego E. Arias, MD
Co-Authors
Justin Hanson BA, Edward Holland MD, Albert Cheung MD, Mehron Kouhestani MS
Purpose
To validate the newly proposed Neurotrophic Keratopathy Study Group (NKSG) staging system for neurotrophic keratopathy (NK) in a cornea and comprehensive ophthalmology clinic. Comparisons of the Mackie and NKSG classifications were made regarding both stage and visual acuity (VA) for NK eyes.
Methods
A retrospective chart review was conducted for patients whose corneal sensation was tested. The study population included 314 total eyes, of which 159 had impaired corneal sensation. Demographic data, past ocular history, and clinical characteristics were gathered. The eyes were then classified into Mackie and NKSG stages based on their slit lamp biomicroscopy exam. The patients were followed through subsequent visits to determine their clinical course, including treatments and progression of Mackie and NKSG staging. The primary outcome measures were NK stage and visual acuity.
Results
Fifty-three NK eyes (33%) were found to be both Mackie 1 and NKSG 4 at initial diagnosis. The mean initial VA for Mackie 1 eyes (20/80) was not statistically different from NKSG 4 eyes (20/150) [p=0.1156]. In contrast, the mean initial VA for Mackie 1 eyes (20/80) was strongly statistically different from NKSG 1 and 2 eyes (20/60) [p=0.0009]. After an average follow-up of 16 months, the mean VA at last follow-up for Mackie 1 eyes (20/80) was not statistically different from NKSG 4 eyes (20/100) [p=0.0627]. In contrast, the mean VA at last follow-up for Mackie 1 eyes (20/80) was strongly statistically different from NKSG 1 and 2 eyes (20/50) [p =0.0010].
Conclusion
Both Mackie 1 and NKSG 4 include corneal stromal haze and scarring, indicative of advanced disease; thus, had similar VA outcomes. Additionally, mild Mackie and mild NKSG eyes had vastly different VA outcomes. Due to the disparities seen in Mackie stage 1 eyes, NKSG appears to be a better system for staging of NK and gives more prognostic value.
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